MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-ARTHROSCOPY PACK

Catalog Number	DYNJ64242B
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "we returned several custom packs a few weeks ago because they arrived soaking wet.Evidently they were repackaged and sent back to us for use.".
Additional Manufacturer Narrative
The complaint transcript noted wet packs redelivered to customer and "potentially used on patient." a photo and a sample were received for investigation; the account returned four packs, no physical damage or discoloring was observed, finished good production records were reviewed with no non-conformances noted, and finished good pack build was reviewed.The investigation summary states that the delivery person left some cases of this product outside while it was raining, the facility sent it back to medline, and the branch showed no signs of damaged and returned the product back to stock and the account received them again; based on the complaint details, the reported damage occurred after kit assembly during transit or storage of the pack, and the root cause is considered an operations service issue.Per the facility the device was not used on a patient and therefore no patient involvement; there was no serious injury identified, follow up care needed or medical intervention reported related to the incident.There were no reports of death, serious injury, medical intervention, or follow up care.This is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: DBD-ARTHROSCOPY PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: namirah khan ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50897611
• Report Number: 1417592-2026-50874
• Device Sequence Number: 10761927
• Product Code: OJH
• UDI-Device Identifier: 40193489956406
• UDI-Public: 40193489956406
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: DYNJ64242B
• Device Lot Number: 22HMD098
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/21/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2023
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown